(Effect of Toy Nebulizer Versus Distraction Cards on Children's Fear and Parental Satisfaction During Nebulization Therapy: A Comparative Study

May 22, 2026 updated by: Mohammed Namir Saeed, University of Baghdad

Goal To compare the effectiveness of a toy nebulizer versus distraction cards in reducing fear among children during nebulization therapy while improving parental satisfaction.

Aim To evaluate and measure children's fear levels and parents' satisfaction when using toy nebulizers compared to distraction cards in nebulization sessions.

Null hypothesis: (Hᴏ) There is no statistically significant difference in fear levels among children, and parental satisfaction scores in in the toy nebulizer, distraction cards, and control groups.

Alternative hypothesis: (H₁) There is a statistically significant difference in fear levels among children, and parental satisfaction scores in the toy nebulizer, distraction cards, and control groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background Nebulization therapy is essential for children with respiratory conditions like asthma, but it often causes significant fear and anxiety in young patients. Distraction techniques help reduce distress, yet more engaging methods like toy nebulizers may offer better outcomes. This study compares these two non-pharmacological interventions.

Study Design A comparative randomized controlled trial involving children aged 3-8 years undergoing nebulization. Participants are randomly assigned to either a toy nebulizer group (interactive play device mimicking nebulization) or distraction cards group (visual/pictorial cards). Fear levels are assessed using the Child Fear Scale (CFS), and parental satisfaction via a 5-point Likert scale.

Objectives Primary: Measure reduction in children's fear during therapy.

Secondary: Evaluate parental satisfaction and therapy completion rates.

Procedures Sessions occur in a pediatric clinic over 4 weeks (3 sessions per child). Pre- and post-session assessments capture fear and satisfaction data. Data analysis uses t-tests and ANOVA for statistical significance (p<0.05).

Expected Outcomes Toy nebulizers are hypothesized to lower fear more effectively than distraction cards, leading to higher parental satisfaction and better adherence to therapy.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:Children aged 3-6 years receiving nebulization therapy for the first time due to acute respiratory conditions (e.g., asthma or bronchitis).

2. Presence of at least one parent (preferably the mother) during the procedure who is capable of evaluation and communication in Arabic or Kurdish.

3. Children who are alert and able to cooperate (absence of severe pain or any condition preventing basic communication).

4. Voluntary written informed consent obtained from the parents and assent from the child (where applicable).

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Exclusion Criteria:Prior history of nebulization therapy (to ensure the fear response is not conditioned by past experiences).

2. Children with cognitive, neurological, or developmental disabilities, or severe chronic illnesses (e.g., terminal cancer).

3. Parental inability to complete fear or satisfaction questionnaires due to disability or illiteracy.

4. Refusal to participate by the child or parent, or the presence of emergency conditions requiring immediate life-saving intervention.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Distraction Card
Behavioral: distraction card
Set of 3-6 colorful picture cards featuring engaging images (animals, counting games, hidden objects) held 12-18 inches from the child's face during nebulization. Nurse flips cards every 1-2 minutes while prompting interactive questions (e.g., "How many stars?" or "Find the bear") to cognitively distract the child aged 3-6 from the mask, promoting calm breathing over 10-15 minute sessions (3x/week for 4 weeks). Used as non-physical, passive distraction in the control arm.
Experimental: toy
Behavioral: Nebuliser toy
Children aged 3-6 receive nebulization therapy using an interactive toy nebulizer (animal-shaped mask with playful features like a blow-out tongue). Nurse guides play-based breathing games during 10-15 minute sessions (3x/week for 4 weeks) to reduce fear while delivering medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Satisfaction scale
Time Frame: 9 month
The one-dimensional PSS is a self-administered questionnaire consisting of 11 statements or items.Each statement had five Likert scale responses ranging from one to four with score 1 representing strongly disagree and score 5 representing strongly agree. Higher scores indicate higher level of satisfaction on the interpersonal relationship with professional. The respondents were asked to choose one best response for each statement.
9 month
Children's Emotional Manifestation Scale
Time Frame: 9 month
Children's Emotional Manifestation Scale: instruction Observe the child's behaviour throughout the entire medical procedure. Once the procedure is finished, immediately select in each category the number that most closely describes the observed behaviour during the procedure. Always refer back to the operational definition when you have difficulty or are unclear in rating the child's behaviour. Each category is scored on a 1-5 scale, resulting in a total score of 5 -25. These child behaviours will determine the extent of their fear of nebulizer.
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UOB-CON-2026-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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